SUPPLY CHAIN ARTICLES
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The RNA Therapeutics Supply Chain: A Platform of Relationships
Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
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Assessing Quality Of mRNA Vaccines: Key Considerations
To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.
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The Price Is… Almost Right: mRNA Edition! COGS Reduction Strategies
The following article will outline the current state of COGS in the mRNA industry and the work he and his colleagues undertook to more effectively utilize raw materials. But heaven forbid this be your normal conference panel write-up. No, below I share Parrella’s insights, but in the form of a never-before released episode of The Price is Right…or perhaps more fittingly given the state of the industry today, this spectacle is more aptly titled: The Price is…Sort Of, Almost, Not Quite Right!
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Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control
Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
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Multidisciplinary mRNA: What Can We Learn From Other CGTs?
Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.
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Chemical modifications on CRISPR gRNAs enhance stability, editing efficiency, and reduce immune responses, enabling in vivo applications and clinical success.
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Explore ongoing work to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene therapy manufacture.
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Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
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Cryopreservation eliminates rigid timelines by decoupling collection from production, providing the flexibility needed to optimize facility use and stabilize advanced therapy supply chains.
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Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.
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Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.